Navigation Links
FDA Accepts Arno Therapeutics' IND for AR-12 a PDK1 Inhibitor That Blocks the PI3K/Akt Pathway
Date:5/11/2009

PARSIPPANY, N.J., May 11 /PRNewswire-FirstCall/ -- Arno Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on oncology therapeutics, today announced that the U.S. Food and Drug Administration ("FDA") accepted the Company's Investigational New Drug ("IND") application for the use of AR-12, a potentially first-in-class, orally available, PDK1 inhibitor that blocks the PI3K/Akt pathway and induces the endoplasmic reticulum stress pathway. Acceptance of the IND permits Arno to initiate a Phase I clinical trial in adults with advanced or recurrent solid tumors or lymphoma for which no standard therapy is available. Arno expects the Phase I clinical trial to begin during the second half of 2009 and will be designed to assess the safety and early evidence of activity of AR-12.

"We are excited that AR-12 has received IND acceptance by the FDA allowing us to begin our Phase I studies. Our preclinical data has demonstrated that AR-12 is active in a wide range of tumor types and it also shows promising activity in combination with several widely used approved cytotoxic as well as molecularly targeted anti-cancer agents," stated Dr. Roger G. Berlin, Chief Executive Officer of Arno.

About AR-12

AR-12 is a potentially first-in-class, orally available, PDK1 inhibitor that blocks the PI3K/Akt pathway and induces the endoplasmic reticulum stress pathway.

About Arno Therapeutics

Arno Therapeutics, Inc. is a clinical-stage biopharmaceutical company that develops and commercializes innovative products for the treatment of cancer patients. Arno's lead clinical development compound is AR-67, a novel, third-generation camptothecin analogue which has completed patient enrollment of its Phase I studies in patients with advanced solid tumors, that has demonstrated high preclinical potency and improved pharmacokinetic properties when compared with marketed second-generation products in its class. Arno is also developing two additional drug candidates. AR-12 is a potential first-in-class, orally available PDK1 inhibitor that blocks the PI3K/Akt pathway and induces the endoplasmic reticulum stress pathway, that received FDA acceptance of its IND in the second quarter of 2009. AR-42, an orally available, targeted inhibitor of the Pan-DAC and Akt pathways received FDA acceptance of its IND in the first quarter of 2009.

For more information on Arno please visit www.arnothera.com.

Forward Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding the timing, progress and anticipated results of the clinical development, regulatory processes, potential clinical trial initiations, potential IND and NDA filings, as well as our strategy, future operations, outlook, milestones, the success of Arno's product development, future financial position, future financial results, plans and objectives of management, are forward-looking statements. We may not actually achieve these plans, intentions or expectations and Arno cautions investors not to place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Various important factors that could cause actual results or events to differ materially from the forward-looking statements that we make. Such factors include, among others, risks that the results of clinical trials will not support our claims or beliefs concerning the effectiveness of our product candidates, our ability to finance the development of our product candidates, regulatory risks, and our reliance on third party researchers and other collaborators. Arno is providing this information as of the date of this presentation and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.


'/>"/>
SOURCE Arno Therapeutics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Food and Drug Administration Accepts Isolagens Biologics License Application for Full Review
2. FDA Accepts Complete Response Submission to New Drug Application for NEBIDO(R)
3. European Regulatory Agency Accepts Cell Therapeutics, Inc.s Marketing Authorization Application for XYOTAX(TM) for Lung Cancer for Review
4. FDA Accepts Investigational New Drug Application for ARI-2243 and a First in Man Clinical Trial Set to Begin During the First Half of 2008
5. FDA Accepts Wyeths Supplemental New Drug Application for Tygacil for the Treatment of Patients with Community-Acquired Pneumonia
6. Logical Therapeutics Appoints Peter A. Lankau as CEO and Director
7. Arcion Therapeutics Topical Pain Candidate, ARC-4558, Significantly Reduces Pain Caused by Diabetic Neuropathy
8. Trius Therapeutics Announces Presentations Featuring Torezolid Antibiotic at the 19th European Congress of Clinical Microbiology and Infectious Diseases
9. Hyperion Therapeutics Receives Orphan Drug Designation for HPN-100 for the Treatment of Urea Cycle Disorders
10. Sirion Therapeutics Announces Clinical Data Presentations at the 2009 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting
11. Intarcia Therapeutics, Inc. Announces Completion of Enrollment of ITCA 650 Phase 1b Study for the Treatment of Type 2 Diabetes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)... 24, 2016 Cirujanos holandeses han ... a los médicos a compartir sus mejores prácticas por ... mundial. Profesionales médicos de Europa, África, Asia ... a la aplicación, que combina la transmisión en vivo ... seguro. Educación   "Imagine un médico ...
(Date:5/24/2016)... 2016   , Study ... overall bowel cleansing and superiority in , ... of the ascending colon ... Norgine B.V. today announced new positive data from the ... bowel preparation) versus standard 2 litre PEG with ascorbate. The study ...
(Date:5/24/2016)... New Zealand , May 24, 2016 ... and informatics solutions for the healthcare sector, has been named ... New Zealand Hi-Tech Awards 2016. Dr Bruce ... fantastic acknowledgement for our team.  It,s really good to be ... burden healthcare internationally. Our products are used in 35 countries ...
Breaking Medicine Technology:
(Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... W.S. ... products, has been honored with a 2016 When Work Works Award for its use ... part of the national When Work Works project administered by the Families and Work ...
(Date:5/26/2016)... ... , ... Connor Sports, through its Connor Cares initiative, will continue ... Catchings Legacy Tour that will commemorate the Indiana Fever legend’s hall-of-fame career and ... forms and levels of the game, Connor Sports has committed to a significantly increased ...
(Date:5/26/2016)... ... May 26, 2016 , ... There are nearly 14.5 million people living with ... worldwide. On Sunday, June 5, 2016, communities around the world will gather to recognize ... , National Cancer Survivors Day® is an annual worldwide Celebration of Life that is ...
(Date:5/26/2016)... ... May 26, 2016 , ... An April Gallup survey found rising health care ... of Sun Health Senior Living (SHSL) may not share those same worries ... prescription copays for the year, while holding the line on increasing their contributions, including ...
(Date:5/26/2016)... ... 26, 2016 , ... Eating Recovery Center, Washington ... a brand new child and adolescent residential treatment center on June 1. The ... more specialized eating disorder treatment and access to life-saving care. , To celebrate, ...
Breaking Medicine News(10 mins):